scholarly journals Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)

2018 ◽  
Author(s):  
Nancy J. Butcher ◽  
Andrea Monsour
Keyword(s):  
Clinical Trials ◽  
Delphi Study ◽  
Guideline Development ◽  
Poor Quality ◽  
Consensus Meeting ◽  
Reporting Guideline ◽  
Research Quality ◽  
Outcome Reporting ◽  
Trial Protocols ◽  
Implementation And Dissemination

Background: Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize and build upon study findings and impacts evidence-based decision making by patients, clinicians, and policy makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT), is being developed. The final product will provide unique InsPECT Extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines.Methods: The InsPECT CONSORT and SPIRIT Extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of: (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a nine-point Likert scale, completed by trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. Discussion: InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

scholarly journals Guidance for reporting outcomes in clinical trials: scoping review protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023001 ◽  
Author(s):  
Nancy J Butcher ◽  
Emma J Mew ◽  
Leena Saeed ◽  
Andrea Monsour ◽  
Alyssandra Chee-a-tow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Grey Literature ◽  
Reference List ◽  
Evidence Based ◽  
Outcome Reporting ◽  
Trial Outcome ◽  
Trial Protocols ◽  
Review Protocol ◽  
Electronic Bibliographic Database

IntroductionPatients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes.Methods and analysisWe will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources.Ethics and disseminationA paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

scholarly journals Guidance for Reporting Outcomes in Clinical Trials: A Scoping Review Protocol

2018 ◽  
Author(s):  
Nancy J. Butcher ◽  
Emma Mew ◽  
Leena Saeed ◽  
Andrea Monsour ◽  
Alyssandra Chee-a-tow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Grey Literature ◽  
Open Science ◽  
Evidence Based ◽  
Reporting Standard ◽  
Outcome Reporting ◽  
Trial Outcome ◽  
Trial Protocols ◽  
Electronic Bibliographic Database

Introduction: Patients, families, and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesize, replicate, or build on existing research findings. To facilitate harmonized reporting of outcomes in published trial protocols and reports, a new reporting standard, the Instrument for reporting of Planned Endpoints in Clinical Trials (InsPECT), is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesize existing guidance on the reporting of trial outcomes. Methods and analysis: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference and citation list screening will be performed for included documents. Two trained reviewers will complete title and abstract screening. One reviewer and one verifier will independently complete full-text screening and data charting. Discrepancies will be resolved through discussion with a third reviewer. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute, and refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (e.g., frequencies) to characterize guidance and its sources. Ethics and dissemination: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardizing trial outcome reporting. Registration details: This protocol was registered prospectively with the Open Science Framework (https://osf.io/ktg84/).

scholarly journals Consensus on tasks to be included in a return to work assessment for a UK firefighter following an injury: an online Delphi study

2021 ◽  
Author(s):  
Liam Noll ◽  
Adrian Mallows ◽  
Jason Moran
Keyword(s):  
Occupational Health ◽  
Return To Work ◽  
Delphi Study ◽  
Online Survey ◽  
Consensus Meeting ◽  
Total Distance ◽  
Portable Pump ◽  
Work Assessment ◽  
Health Managers

Abstract Objective The aim was to provide a consensus tasks needed to be included in a return to work assessment for operational firefighters. Methods A two round online Delphi study was conducted with twenty-four participants including firefighters, service fitness advisers and occupational health managers. A consensus was set at 70% agreement. In round one, participants completed an online survey relating to tasks to be included during a return to work assessment for firefighters following an injury. Round two was an online consensus meeting to discuss the tasks where consensus was not achieved. Results A consensus was reached for ten of the thirteen tasks, including the number of repetitions required when lifting a light portable pump and climbing a ladder. A consensus was reached for the total distance equipment which should be carried. This included carrying a ladder, a hose and a light portable pump. Conclusions This study has provided a consensus for tasks to be included when assessing a firefighter for return to work. Further research is needed to understand how to use this assessment optimally

Selective outcome reporting in root coverage randomized clinical trials

2021 ◽  
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Root Coverage ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

scholarly journals Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5864-5864
Author(s):  
Amany R. Keruakous ◽  
Adam S. Asch
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cultural Bias ◽  
Cancer Center ◽  
Exclusion Criteria ◽  
Strict Inclusion ◽  
Trial Protocols ◽  
Trial Staff ◽  
Disease Site ◽  
Patient Enrolment

Background: Clinical trials, key elements of the processes that account for many of the recent advances in cancer care, are becoming more complex and challenging to conduct. The Stephenson Cancer Center (SCC) has been the lead accruer to NCI-LAP trials over the past three years, and in addition, fields investigator initiated and industry sponsored trials. To identify opportunities for continued improvement in clinical trial enrolment, we sought to identify the obstacles encountered by our clinical trial staff in these activities. Method: We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection and compliance. The survey, sent by email to the clinical trial list-serve at SCC (90 staff member), invited respondents to enumerate obstacles to patient participation in clinical trials. We then performed a follow up meeting with our research coordinators to clarify responses. A total of 26 responses from 90 respondents were received and tabulated by disease site. Results: The most commonly reported obstacles to enrolment were, in descending order: communication/language barriers, cultural bias, time/procedure commitment, and complexity of the trial protocol, financial logistics, comorbidities, and stringent trial criteria. Respondents identified 83 obstacles as frequently encountered obstacles to enrolment. The 83 reported obstacles were classified into 9 categories and organized by disease site as presented in tabular format (below). The most commonly identified obstacles to patient enrolment were communication and language barriers. In patients for whom Spanish is the primary language this was a universal obstacle, as there is a lack of consistent Spanish consents across the clinical trial portfolio. Cultural bias, as an obstacle was manifested as a general mistrust by prospective trial participants of experimental therapies and clinical trials. After communication and cultural bias as barriers, travel requirements and the associated expenses playing a role in patients from rural areas were identified as the most commonly encountered barrier. The complexity of trial protocols and the associated large number of clinic visits, frequent laboratory and imaging tests were also identified as common obstacles. Clinical trial complexity with strict inclusion and exclusion criteria and trial-specified biopsies were frequently cited. Implications: In this descriptive study, common barriers to patient enrolment in clinical trials were identified by clinical trial staff. Assessing barriers encountered by clinical trial staff is infrequently used as a metric for improving clinical trial enrolment, but provides important perspective. In our study, some obstacles are inherent in our patient populations, others appear to be actionable. Development of Spanish language consents and specific programs to overcome negative bias regarding clinical trials are potential areas for improvement. The complexity of clinical trial protocols and the increasingly strict inclusion/exclusion criteria, are issues that will require consideration and action at the level of the cooperative groups and industry. Disclosures No relevant conflicts of interest to declare.

P361 What influences participation in clinical trials by people with cystic fibrosis? A national delphi study

2020 ◽  
Vol 19 ◽  
pp. S157
Author(s):  
R. Dobra ◽  
S. Elborn ◽  
S. Madge ◽  
L. Allen ◽  
C. Saunders ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Delphi Study

scholarly journals Can prospective systematic reviews of animal studies improve clinical translation?

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Animal Studies ◽  
Poor Quality ◽  
Human Studies ◽  
Clinical Knowledge ◽  
Safety And Efficacy ◽  
High Quality Evidence ◽  
Animal Data

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.

scholarly journals Significant influencing factors and practical solutions in improvement of clinical nursing services: a Delphi study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sarieh Poortaghi ◽  
Abbas Ebadi ◽  
Mahvash Salsali ◽  
Afsaneh Raiesifar ◽  
Nayyereh Davoudi ◽  
...  
Keyword(s):  
Delphi Study ◽  
Poor Quality ◽  
Clinical Services ◽  
Policy Makers ◽  
Factors Affecting ◽  
Nursing Managers ◽  
Clinical Nursing ◽  
Communication Program ◽  
Nursing Services

Abstract Background Clinical services evaluation with specific indicators are very helpful to identify improvable points. This study was conducted to analyze the factors affecting the quality of clinical nursing services and offer practical solutions for accreditation of clinical nursing services. Methods The present study was conducted using Delphi method with two rounds. At the beginning of the study a questionnaire was prepared using results of another project (clinical nursing services audit). This questionnaire was sent to 47 nursing and accreditation professionals. After the first round, causes and solutions were categorized. Then participants were asked to comment on the significance of each strategy on the prepared questionnaire. Results In the first round of Delphi in response to the question about the main causes and solutions of low quality of nursing clinical services, 394 causes and 212 solutions were mentioned by the participants. In the second round, considering moralists and specialization in the selection of nursing managers, staffing according to workload and attendance in comprehensive exam after graduation and before entering clinical fields attained the most importance. Conclusion Mismatch of human resources with workload and lack of clarity with regard to duties have maximum correlation with poor quality of care. Organizational structure and communication program categories gained the highest and lowest importance respectively. This information could be used by nursing managers and policy makers to plan programs in order to improve the quality of clinical nursing services.

Sign in / Sign up

Export Citation Format

Share Document